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Dovato

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REAL-WORLD EVIDENCE

DOVATO IS NOW BEING ASSESSED IN TREATMENT-NAÏVE PATIENTS IN THE REAL WORLD

Looking at the larger treatment naïve studies (effectiveness outcomes with >30 patients) we can see Dovato has low rates of virological failure with a consistent high barrier to resistance4-10

RWE Tx Naive Summary Graphic used on Dovato Vx

DTG 50 mg + 3TC 300 mg used in most reported real-world studies.

This bar graph for real-world evidence shows the high virological effectiveness of DOVATO across 6 of the real-world studies.

DTG 50 mg + 3TC 300 mg used in most reported real-world studies.
*Virological effectiveness was 85.2% in the intent-to-treat–exposed analysis.
†Loss of suppression defined as 2 consecutive HIV-1 viral loads ≥200 copies/mL in individuals who have initially achieved virological suppression; blips defined as HIV-1 viral loads >50 copies/mL after initially achieved virological suppression.

TOLERABILITY YOU EXPECT FROM DTG + 3TC IN REAL-WORLD STUDIES

Studies Reporting Discontinuations Due to AEs With ≥20 Patients (n=3/10)

RWE Tx Naive Tolerability Graph used in Viiv Exchange

AE=adverse event.
DTG 50 mg + 3TC 300 mg used in most reported real-world studies.
Percentage calculated based on overall N on DOVATO as the denominator.

SWITCH TO DOVATO: GROWING REAL-WORLD DATA CONTINUE TO REINFORCE ROBUST EFFICACY

Looking at the larger treatment experienced studies (effectiveness outcomes with >250 patients) we can see dovato has low rates of virological failure with a consistent high barrier to resistance8,10,15,19

Real-World Evidence Baseline Characteristics Switch Patients

DTG 50 mg + 3TC 300 mg used in most reported real-world studies.

This bar graph for real-world evidence shows the high virological effectiveness of DOVATO across 6 of the real-world studies.

DTG 50 mg + 3TC 300 mg used in most reported real-world studies.
*18 virological rebound events (calculation assumes ≤1 virological rebound event per patient).
†Virological failure defined as confirmed viral load >50 copies/mL or one single viral load >200 copies/mL.
‡Loss of suppression defined as 2 consecutive HIV-1 viral loads ≥200 copies/mL in individuals who have initially achieved virological suppression; blips defined as HIV-1 viral load >50 copies/mL after initially achieved virological suppression.
§Confirmed virological failure defined as 2 viral loads ≥200 copies/mL or discontinuation after 1 viral load ≥200 copies/mL.

TOLERABILITY YOU EXPECT FROM DTG + 3TC IN REAL-WORLD STUDIES

Studies Reporting Discontinuations Due to AEs With ≥100 Patients (n=4/16)

Real-World Evidence Switch Tolerability

AE=adverse event.
DTG 50 mg + 3TC 300 mg used in most reported real-world studies.
Percentage calculated based on overall N on DOVATO as the denominator.

Bar chart

The efficacy of DOVATO has been proven in clinical trials

See the Data

Shield

Real-world evidence also confirms the high barrier to resistance of DOVATO

Explore the High Barrier to Resistance

References:

  1. Montaner JS, Wood E, Kerr T et al. Expanded highly active antiretroviral therapy coverage among HIV-positive drug users to improve individual and public health outcomes. J Acquir Immune Defic Syndro. 2010;55 Suppl. 1:5
  2. Eisinger RW, Dieffenbach CW, Fauci AS. HIV VIral Load and Transmissibility of HIV Infection: Undetectable Equals Untransmittable. JAMA. 2019;321(5):451-452.
  3. Pierone G, Fusco JS, Brunet L, et al. Suppressed switch to DTG/3TC 2-drug regimen vs. BIC- or DTG-based 3-drug regimens. Presented at: IDWeek 2022; October 19-23, 2022; Washington, DC, USA. Poster.
  4. Cabello A, López Bernaldo de Quiros JC, Pulido F, et al. 48 weeks efficacy and tolerability of dolutegravir (DTG) + lamivudine (3TC) in adult HIV naïve patients: a multicenter real life cohort. Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual.
  5. Calza L, Legnani G, Fulgaro C, et al. Changes in serum inflammatory markers in antiretroviral therapy-naïve HIV-infected patients starting dolutegravir/lamivudine or dolutegravir/lamivudine/abacavir. J Acquir Immune Defic Syndr. 2022;89(3):e30. doi:10.1097/QAI.0000000000002861
  6. Dou Y, Li Y, Hong Z, et al. The efficacy of DTG+3TC in naïve HIV patients—the real world data from southern China. Presented at: 18th European AIDS Conference; October 27-30, 2021; London, England. Poster PE2/19.
  7. Hidalgo-Tenorio C, Pasquau J, Vinuesa D, et al. DOLAVI real-life study of dolutegravir plus lamivudine in naïve HIV-1 patients (48 weeks). Viruses. 2022;14(3):524. doi:10.3390/v14030524
  8. Nasreddine R, Yombi JC, Darcis G, et al. Efficacy, durability, and tolerability of dolutegravir/lamivudine and dolutegravir/rilpivirine for the treatment of HIV in a real-world setting in Belgium. Presented at: 11th edition of the AFRAVIH Conference; April 6-9, 2022. Marseille, France. Oral CO4.1.
  9. Schneider S, Burke C, Ward D, et al. Treatment experience of single-tablet dolutegravir/lamivudine in the United States: results from the ‘real-world outcomes with dolutegravir-based two-drug-regimens Dovato and Juluca for the treatment of HIV-1' (TANDEM study). Presented at: The 24th International AIDS Conference; July 29-August 2, 2022; Montreal, Canada. Poster EPB147.
  10. Scholten S, Noe S, Wyen C, et al. 12-month outcomes of dolutegravir (DTG) + lamivudine (3TC) in ART-naïve and pre-treated people living with HIV in Germany: real-world data from the German URBAN cohort. Presented at: 18th European AIDS Conference; October 27-30, 2021; London, England. Poster PE2/52.
  11. Ciccullo A, Baldin G, Dusina A, et al. Short communication: efficacy and safety of dolutegravir plus lamivudine as a first-line regimen in clinical practice. AIDS Res Hum Retroviruses. 2021;37(6):486-488. doi:10.1089/AID.2020.0276
  12. Gianotti N, Tavell A, Antinori A, et al. Are patients starting first-line ART with a 2-drug regimen (2DR) with dolutegravir/lamivudine different from those initiating 3-drug regimens (3DR) based on an integrase strand transfer inhibitor (InSTI), plus tenofovir alafenamide/emtricitabine. Presented at: The 11th IAS Conference on HIV Science; July 18-21, 2021. Poster A-IAS2021-00429.
  13. Stephenson L, Pan D. Clinical experience of dolutegravir + lamivudine dual treatment regimens at University Hospital Leicester NHS Trust. Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual.
  14. Mendoza I, Lázaro A, Torralba M. Effectiveness, durability, and safety of dolutegravir and lamivudine versus dolutegravir, lamivudine, and abacavir in a real-life cohort of HIV-infected adults. Annal of Pharm. 2022;56(4):412-421. doi:10.1177/10600280211034176
  15. Bravo O, Martínez-Alfaro E, Galera C, et al. Multi-central study to evaluate effectiveness and safety of the dolutegravir and lamivudine biterapy in vida real. Presented at: Grupo de Estudio del Sida-Seimc; December 10-13, 2019; Toledo, Spain. Abstract P-145.
  16. Gagliardini R, Lorenzini P, Cozzi-Lepri A, et al; for the Icona Foundation Study Group. Effect of past virological failure on dolutegravir + lamivudine as maintenance regimen. Presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, MA. Poster 0486.
  17. Hocqueloux L, Allavena C, Sécher S, et al. Archived mutation M184V does not increase virologic failure during maintenance therapy with dolutegravir + lamivudine in the French DAT’AIDS cohort. Presented at: 18th European AIDS Conference; October 27-30, 2021; London, England. Oral Session OS1-2.
  18. Krentz HB, Campbell S, Lahl M, Gill MJ. Uptake success and cost savings from switching to a two-drug antiretroviral regimen. AIDS Patient Care STDS. 2022;36(1):1-7. doi:10.1089/apc.2021.0118
  19. Pierone G, Brunet L, Fusco JS, et al. Switching to dolutegravir/lamivudine two-drug regimen: durability and virologic outcomes in routine U.S. clinical care. Presented at: The 24th International AIDS Conference; July 29-August 2, 2022; Montreal, Canada. Poster.
  20. Amor García MA, Rodríguez-González CG, Chamorro-de-Vega E, Herranz-Alonso A, Sanjurjo-Sáez M. Dolutegravir-based dual therapies in HIV pretreated patients: a real-life study in Madrid. Ann Pharmacother. 2022;56(4):401-411. doi:10.1177/10600280211038504
  21. Calza L, Colangeli V, Borderi M, et al. Simplification to dual therapy containing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy. J Antimicrob Chemother. 2020;75(11):3327-3333. doi:10.1093/jac/dkaa319
  22. Maggiolo F, Gulminetti R, Pagnucco L, et al. Five years durability of dolutegravir + lamivudine in patients with suppressed HIV-RNA. Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual.
  23. Tan M, Johnston S, Nicholls J, Gompels M. Dual therapy with renally adjusted lamivudine and dolutegravir: a switch strategy to manage comorbidity and toxicity in older, suppressed patients? HIV Medicine. 2019;20(9):634-637. doi:10.1111/hiv.12781
  24. Uriel AJ, Banks T, Ashton K, et al. Dual antiretroviral (ARV) therapy: safe and efficacious even in a heavily ARV experienced real-world cohort. Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual.
  25. Yagci-Caglayik D, Gokengin D, Inan A, et al. Real life experience of dolutegravir and lamivudine dual therapy as a switching regimen in HIVTR cohort. Presented at: The 16th European AIDS conference; October 25-27, 2017. Milan, Italy.
  26. Haidari G, Barchi W, Chilton D, Kulasegaram R. Dolutegravir/lamivudine (DTG/3TC) in people living with HIV (PLWH) as a switch or start: a London based experience. Presented at: The 18th European AIDS conference, October 27-30th, 2021. London, United Kingdom.
  27. Bowman C, Ambrose A, Simons P, et al. Performance of dolutegravir based two drug regimens (DTG-2DR) in a large real-world cohort of people with HIV. Presented at: The British HIV Association Spring Conference 2022; April 20-22, 2022. Manchester, United Kingdom. Poster.
  28. Hiryak K, Kludjian G, Samuel R, et al. Real-world implementation of dolutegravir-lamivudine to achieve and maintain HIV-1 viral suppression at an academic medical center. Presented at: ID Week; October 21-25, 2020; Virtual.
  29. Ma J, Nance RM, Delaney JAC, et al. Current antiretroviral treatment among people with HIV in the US: findings from the CNICS cohort. J Clin Inf Dis. 2022;1-15. doi:10.1093/cid/ciac086
  30. Alves Correia RM, Carvalho AC. Real life study with dual therapy in a HIV-1 treatment experienced Portuguese Cohort. Presented at: The 23rd International AIDS Conference; July 6-10, 2020. Virtual. Poster PEB0235.
  31. Cucchetto G, Lanzafame M, Nicolé S, et al. Integrase inhibitors with lamivudine, as maintenance-dual therapy, in a real-life clinical settings. Presented at: The Italian Conference on AIDS and Retroviruses, June 6-8 2016, Milan, Italy. P69.
  32. Pasqua Liaño J, Sequera Arquelladas S, López-Cortez, et al. DOLAM study 200: effectiveness safety and economic evaluation of a dual therapy with dolutegravir plus lamivudine in treatment-experienced HIV patients. Presented at: The 18th European AIDS conference, October 27-30th, 2021. London, United Kingdom. Poster PE2-38.
  33. Fernández Zamora C, Rodriguez Martinez T, Merono Saura MA, et al. Effectiveness of dolutegravir and lamivudine therapy in a two drug regimen in a third level hospital. Eur J Hosp Pharm. 2020;27(suppl 1):A79. doi:10.1136/ejhpharm-2020-eahpconf.169
  34. Santoro MM, Armenia D, Teyssou E, et al. Impact of M184V on the virological efficacy of switch to 3TC/DTG in real life. Presented at: CROI 2021. Poster.
  35. Lanzafame M, Nicole S, Rizzardo S, et al. Immunovirological outcome and HIV-1 DNA decay in a small cohort of HIV-1 infected patients deintensificated from abacavir/lamivudine/dolutegravir to lamivudine plus dolutegravir. New Microbiol. 2018;41(4):262-267.
  36. Malagnino V, Teti E, Compagno M, et al. HBcAb positivity is a risk factor for an increased detectability of HIV RNA after switching to a two-drug regimen lamivudine-based (2DR-3TC-based) treatment: analysis of a multicenter Italian cohort. Microorganisms. 2021;9(2):396. doi:10.3390/microorganisms9020396
  37. Ciccullo A, Borghi V, Giacomelli A, et al. Five years with dolutegravir plus lamivudine as a switch strategy: much more than a positive finding. J Acquir Immune Defic Syndr. 2021;88(3):234-237. doi:10.1097/QAI.0000000000002787
  38. Pereira Goulart S, de Albuquerque Moras C, Furtado da Costa A, et al. ART simplification: use of dual therapy for HIV in a public health reference center (CRT-DST/Aids) in São Paulo, Brazil. Presented at: 17th European AIDS Conference; November 6-9, 2019; Basel, Switzerland. Poster PE2/34.
  39. Rodríguez Alonso B, Úbeda C, Bonilla M, et al. P203 efficacy and tolerance of dolutegravir-based bitherapy (DTG) in simplification outside clinical trials. Presented at: GeSIDA 2017. Poster P203.
  40. Teira R, Diaz-Cuervo H, Aragão F, et al. Shorter time to treatment failure in people living with HIV switched to dolutegravir plus either rilpivirine or lamivudine compared to integrase inhibitor-based triple therapy in a large Spanish cohort (VACH). Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual. Poster P031.
  41. Vergas TJ, Estrada J, Perez-Somarriba J, et al. P-190. Bitherapies without protease inhibitors. a safe and efficient option. Presented at: GeSIDA 2017.
  42. Silva Sombra, Loiola MM, Vasconcelo M, et al. Simplification with lamivudine/dolutegravir dual therapy in HIV patients with real-life virological suppression (LAMDO study). Braz J Infect Dis. 2021;25:(S1). Abstract.
  43. Ruiz-Algueró M, Hernando V, Riero M, et al. Temporal trends and geographic variability in the prescription of antiretroviral treatments in people living with HIV in Spain, 2004-2020. J Clin Med. 2022;11(7):1896. doi:10.3390/jcm11071896

Dovato is a registered trade mark of the ViiV Healthcare group of companies or its licensor.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Date of Preparation: January 2025
PM-IE-DLL-WCNT-240002

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